NDC 54973-3375-01 - 4 Kids Cold and Cough Nighttime

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54973-3375
Requested NDC
54973-3375-01
Package NDCs from labels
54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Cold & Cough NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.]11Current NDC, Legacy NDC, 5 package rows20250209_71e93027-33c9-6147-e053-2a95a90aaa09.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 68 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Serene SleepESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOXThe Wellness Center for Research a2d5bbd0d-9b50-45ce-aa23-05bd05b546452025-06-06WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: 1MBW07J51Q
MBM 5 Large IntestineCOLON (SUIS), HYDRASTIS CANADENSIS, SENNA (CASSIA ANGUSTIFOLIA), CUPRUM METALLICUM, NITRICUM ACIDUM, AGARICUS MUSCARIUS, ARNICA MONTANA, BAPTISIA TINCTORIAThe Wellness Center0804f33c-28d8-4d5d-8002-36e1daa6cca32025-06-06WarningsExact identifier
unii: ZW3Z11D0JV
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.1ba8e7a0-d700-c96b-e063-6394a90a04632025-06-05Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE AND SULFURSODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8%BioComp Pharma, Inc.1ba8bb47-6f7a-28ec-e063-6394a90a8eb32025-06-05Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURBantry Pharma, LLCf433db67-d8a6-320e-e053-2995a90aab522025-06-04Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Balanceforce VLEONURUS CARDIACA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, COCCULUS INDICUS, CONIUM MACULATUM, PETROLEUM, PHOSPHORUS, PULSATILLA (VULGARIS), TABACUM, THERIDIONBioActive Nutritional, Inc.d235f51f-c773-4dd1-84f4-1ee5c3365d132025-06-02WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lymph Detox PlusAPIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, GELSEMIUM SEMPERVIRENS, SOLIDAGO VIRGAUREA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CHELIDONIUM MAJUS, RHUS TOX, LACHESIS MUTUSThe Wellness Center for Research and Education, Inc.fe5d0979-037d-4f43-ae06-8469c85ee5042025-05-29WarningsExact identifier
unii: ZW3Z11D0JV
Bryophyllum AvenaBRYOPHYLLUM AVENAUriel Pharmacy Incf3d21630-0a99-11df-8a39-0800200c9a662025-05-28WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
ENT SupportARGENTUM NITRICUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, EUPHORBIUM OFFICINARUM, GALLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2023-2024), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOR RACEMOSUS, MUTABILE BACILLUS (BACH), PULSATILLA (PRATENSIS), SINUSITISINUMDeseret Biologicals, Inc.284327cc-2d06-4f75-a296-52c34f1496932025-05-27WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products Allium CepaALLIUM CEPABestmade Natural Products29944998-a2df-002d-e063-6294a90ab8bd2025-05-27WarningsExact identifier
unii: 492225Q21H
Bestmade Natural Products - Mullein Ear DropsBELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATABestmade Natural Products299331bd-9318-6d80-e063-6294a90ab8892025-05-27WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products SulphurSULPHURBestmade Natural Products29a63ed5-0e44-572a-e063-6394a90a083b2025-05-27WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products PhosphorusPHOSPHORUSBestmade Natural Products29a54829-7693-c0c0-e063-6294a90ad0692025-05-27WarningsExact identifier
unii: 27YLU75U4W
Bestmade Natural Products Hepar SulphurisHEPAR SULPHURISBestmade Natural Products29a45852-3870-d044-e063-6394a90af82b2025-05-27WarningsExact identifier
unii: 1MBW07J51Q
CamiliaMATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOTLaboratoires Boiron24246729-2d45-4d83-bc25-39db03e266d42025-05-27WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.